Modulating buttress saline mammary prosthesis

Abstract

A saline-filled breast prosthesis has enhanced performance by virtue of having tactile characteristics approximating those of gel-filled implants. The invention retains all the benefits of the recognized safety profile, straight-forward construction, and broad clinical indications for saline implants. An enhanced implantable mammary prosthesis comprises a shell, a slurry filler compartment interior to the shell containing slurry filler, a fluid compartment, the fluid compartment being deformable from a neutral profile under pressure from the slurry filler and which recoils to the neutral profile when not under pressure, a reservoir, the reservoir being disposed external to the shell, the reservoir and fluid compartment being fluidically coupled by a port, and a limiting membrane region disposed between the fluid compartment and the reservoir.

Description

PRIORITY CLAIM[0001]This application claims the benefit of and priority to U.S. Provisional patent application Ser. No. 61 / 024,405, entitled “Modulating Buttress Saline Mammary Prosthesis Gel Simulating Saline Implant”, filed Jan. 29, 2008, hereby incorporated by reference as if fully set forth herein.FIELD OF THE INVENTION[0002]This invention relates to implantable prosthetic devices and to tissue expanders used in plastic and reconstructive surgery used to stretch tissues. More particularly, the invention relates generally to a preferably saline implant that simulates the properties of gel implants.BACKGROUND OF THE INVENTION[0003]Most tissue expanders and soft tissue-simulating implantable prostheses have been utilized to enhance or reconstruct the female breast. While success has been achieved across the spectrum of devices and procedures, the predictability of success has very often been a matter of intelligent guesswork by implanting surgeons. Despite the sometimes fortuitous ...

AI Technical Summary

Benefits of technology

[0008]An enhanced implantable mammary prosthesis comprises a shell and a slurry filler compartment interior to the shell containing slurry filler. A fluid compartment is in pressure transmissive contact with the slurry filler. The fluid compartment is deformable from a neutral profile under pressure from the slurry filler, and it recoils to the neutral profile when not under pressure. A reservoir is disposed preferably external to the shell. The reservoir and the fluid compartment are fluidically coupled by a port. A limiting membrane region is disposed between the fluid compartment and the reservoir to provide sufficient structural rigidity that the pressure transmission from the slurry filler can be effectively transmitted to the fluid compartment and in turn be relieved by expansion of the reservoir by fluid passing from the fluid space through the port. Optionally, additional structures may be provided on or in the fluid compartment to aid in the recoil of the fluid compartment.

[0010]The enhanced-performance slurry of the invention has increased viscosity due to the large number of individual particles within it in frictional interference with other like particles and the ratio of solid to liquid components. Buffered normal saline is the preferred fluid. The “solid-particulate” component ideally is comprised of a prodigious quantity of “closest-packing” diameters of medical glass spheres or biocompatible polymer spheres or micro-toroids which may be textured or metal-plated to enhance their performance. Besides frictional interference, electrostatic forces and surface tension influence overall viscosity. Amorphous glass “frit” can be admixed to increase friction, as well. Silver plated glass particles will additionally confer bacteriostatic properties to such a slurry. The slurry will have an ideal viscosity when it resembles that of thick toothpaste or thin bread dough.

Problems solved by technology

As a consequence, very dense tough scar tissue forms which serves to deform and severely harden what would otherwise be a soft breast.

Sub-muscular placement of implants has increased the complication rate.

Complex multi-component implant constructions including textured shells, “protective” saline compartmentalization around silicone gel compartments, and baffling schemes and others have been tried and eventually rejected as being problematic for a variety of reasons.

Unfortunately, resistance to its broad adoption has been based on esthetic consideration both ex vivo and as implanted.

Its acceptance has been limited by its less than satisfactory “off-clear” appearance, the propensity to wrinkle due to a stiff high density shell and the fact that normal saline filler itself offers little resistance to deformation and is too quick to propagate visible waves on deformation.

Such features have often led to embarrassment for the patient.

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